Soft tissue cutting device and methods of use

ABSTRACT

Some embodiments provide a soft tissue device, such as a transverse carpal ligament cutting device having one or more balloons that are deflated when the device is in an inactive position and are inflated when the device is in an active position. Other embodiments provide a soft tissue cutting method, such as a method of cutting a transverse carpal ligament that uses a soft tissue cutting device.

RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application No.62/052,208, filed Sep. 18, 2015, U.S. Provisional Application No.62/167,543, filed May 28, 2015 and U.S. Provisional Application No.62/192,770 filed Jul. 15, 2015, each of which is incorporated herein byreference.

FIELD OF THE INVENTION

The present invention generally relates to a soft tissue cutting deviceand soft tissue cutting methods. The present invention also relatesgenerally to a transverse carpal ligament cutting device and transversecarpal ligament cutting methods.

BACKGROUND OF THE INVENTION

Carpal tunnel syndrome affects approximately 3.7% of the generalpopulation and up to 7% of manual labor workers. Several varyingsurgical procedures are performed annually to treat patients with carpaltunnel syndrome. One of these surgical procedures is known as a carpaltunnel release procedure (“CTR procedure”). A primary goal of the CTRprocedure is to cut a transverse carpal ligament in order to reducemedian nerve compression and carpal tunnel pressures in the carpaltunnel region.

CTR procedures can be performed by accessing the carpal tunnel primarilyfrom the outside or accessing the carpal tunnel primarily from theinside. In the former, a palmar incision of various sizes is used todirectly visualize and transect the transverse carpal ligament. In thelatter, the transverse carpal ligament is visualized from within thecarpal tunnel using an endoscope advanced through a small palmar and/ordistal wrist incision-endoscopic carpal tunnel release (ECTR).

One concern with CTR procedures is that it is hard to visualize thetransverse carpal ligament and at-risk structures nearby (e.g., a mediannerve and an ulnar artery). It is also hard to visualize individualanatomical variations in the carpal tunnel region. As a result, some CTRprocedures can cause incomplete release of the transverse carpalligament and others can cause injuries to the nearby at-risk structures.

In recent years, operators have used ultrasound guidance with CTRprocedures to better visualize the carpal tunnel region during theprocedure. However, even with the improved visualization of ultrasound,there are still concerns even with these procedures. One concern is thata sharp cutting instrument may be passed into the carpal tunnel withoutthe ability to precisely control deployment of a sharp cuttinginstrument. Thus, the sharp cutting instrument presents a risk to boththe patient and the operator. It would be desirable to provide animproved device that includes a sharp cutting instrument that is notexposed until the cutting of the transverse carpal ligament occurs.

Also, several operators use ultrasound guidance to place a sharp cuttinginstrument in position to cut the transverse carpal ligament but do notutilize ultrasound visualization during the actual cutting. In somecases, this is because the sharp cutting instruments require the use oftwo hands to perform the cutting. Thus, when operators perform thecutting, they are not able to continue holding the ultrasound probeduring cutting. It would be desirable to provide an improved device thatallows for an operator to continue using ultrasound guidance duringcutting. It would also be desirable to provide a device that allows foran operator to use one hand while cutting, so that the opposite hand canhold an ultrasound probe or otherwise engage in providing ultrasoundguidance.

Further, there is typically a very narrow space between the median nerveand the ulnar artery in the carpal tunnel. This narrow space is a “safezone” in which the transverse carpal tunnel ligament can be cut withoutrisk to the median nerve or ulnar artery. This space is variable frompatient to patient and can be less than 3 millimeters in some patients.Consequently, placing a sharp cutting instrument in this region canexpose a patient to risks of injury. It would also be desirable toprovide a device that can expand the “safe zone” in a patient to reducerisks of injury.

SUMMARY

Some embodiments provide a soft tissue device having (a) a shaft havinga top surface, two side surfaces and a bottom surface, wherein the shaftextends along a longitudinal axis, (b) a shaft opening that extends fora distance along the longitudinal axis, (c) a blade that extends throughand withdraws from the shaft opening, and (d) one or more balloonscoupled to the shaft that expand radially outwardly from the shaft.

Other embodiments provide a transverse carpal ligament cutting devicehaving (a) a shaft having a top surface, two side surfaces and a bottomsurface, (b) a shaft opening that extends for a distance along the topsurface, (c) a blade having a top cutting edge, and (d) one or moreballoons coupled to the shaft that expand radially outwardly from theshaft, wherein the top cutting edge is housed within the shaft and theone or more balloons are deflated when the device is in an inactiveposition and wherein the top cutting edge extends upwardly through theshaft opening and the one or more balloons are inflated when the deviceis in an active position.

Other embodiments provide a transverse carpal ligament cutting devicehaving (a) a shaft having a top surface, two side surfaces and a bottomsurface, (b) a shaft opening that extends for a distance along the topwall and two side surfaces, (c) a blade having a distal cutting edge,and (d) one or more balloons coupled to the shaft that expand radiallyoutwardly from the shaft, wherein the distal cutting edge is housedwithin the shaft and the one or more balloons are deflated when thedevice is in an inactive position and wherein the distal cutting edgeextends distally through the shaft opening and the one or more balloonsare inflated when the device is in an active position.

Other embodiments provide a transverse carpal ligament cutting devicehaving (a) a shaft having a top surface, two side surfaces and a bottomsurface, (b) a shaft opening that extends for a distance along the topwall, (c) a blade having a blade working end, wherein the blade workingend includes a cutting edge that faces the proximal end of the device,and (d) a blade guideway within the shaft, wherein the blade working endmoves along the blade guideway.

Other embodiments provide a soft tissue cutting device having (a) ashaft having a plurality of surfaces, (b) a shaft opening that extendsfor a distance along one of the plurality of surfaces, (c) a blade thatextends through and withdraws from the shaft opening, (d) an inflationdevice, a conduit and a balloon, wherein the balloon is coupled to theconduit and the conduit is coupled to the inflation device and whereinthe balloon expands radially outwardly from the shaft.

Other embodiments provide a soft tissue cutting method, comprising thesteps of: (1) providing a soft-tissue cutting device having (a) a shaft,(b) a shaft opening in the shaft, (c) a blade that extends through andwithdraws from the shaft opening, and (d) one or more balloons coupledto the shaft that expand radially outward from the shaft, (2) advancingthe soft-tissue cutting device to a body region, (3) expanding the oneor more balloons radially outward, and (4) extending the blade throughthe shaft opening to cut the soft tissue.

Other embodiments provide a method of cutting a transverse carpalligament, comprising the steps of: (1) providing a cutting device havingan inactive position and an active position, wherein in the inactiveposition the device includes an unexposed blade and one or more deflatedballoons and in the active position the device includes an exposed bladeand one or more inflated radially-expanding balloons, (2) advancing thedevice to a carpal tunnel region while the device is in the inactiveposition, and (3) cutting a transverse carpal ligament while the deviceis in the active position.

BRIEF DESCRIPTION OF THE DRAWINGS

The following drawings are illustrative of particular embodiments of theinvention and therefore do not limit the scope of the invention. Thedrawings are not necessarily to scale (unless so stated) and areintended for use in conjunction with the explanations in the followingdetailed description. Embodiments of the invention will hereinafter bedescribed in conjunction with the appended drawings, wherein likenumerals denote like elements.

FIG. 1 illustrates a side cross-section view of a proximal end of a softtissue cutting device according to an embodiment.

FIG. 2 illustrates a side cross-section view of a distal end of a softtissue cutting device according to a first embodiment, wherein thedevice is in an inactive position.

FIG. 3 illustrates a side cross-section view of a distal end of a softtissue cutting device according to a first embodiment, wherein thedevice is in an active position.

FIG. 4 illustrates top cross-section view of a distal end of a softtissue cutting device according to a first embodiment, wherein thedevice is in an inactive position.

FIG. 5 illustrates top cross-section view of a distal end of a softtissue cutting device according to a first embodiment, wherein thedevice is in an active position.

FIG. 6 illustrates a front cross-section view of a soft tissue cuttingdevice according to a first embodiment, wherein the device is in aninactive position.

FIG. 7 illustrates a front cross-section view of a soft tissue cuttingdevice according to a first embodiment, wherein the device is in anactive position.

FIG. 8 illustrates a side cross-section view of a distal end of a softtissue cutting device according to a second embodiment, wherein thedevice is in an inactive position.

FIG. 9 illustrates a side cross-section view of a distal end of a softtissue cutting device according to a second embodiment, wherein thedevice is in an active position.

FIG. 10 illustrates top cross-section view of a distal end of a softtissue cutting device according to a second embodiment, wherein thedevice is in an inactive position.

FIG. 11 illustrates top cross-section view of a distal end of a softtissue cutting device according to a second embodiment, wherein thedevice is in an active position.

FIG. 12 illustrates a front cross-section view of a soft tissue cuttingdevice according to a second embodiment, wherein the device is in aninactive position.

FIG. 13 illustrates a front cross-section view of a soft tissue cuttingdevice according to a second embodiment, wherein the device is in anactive position.

FIG. 14 illustrates a perspective view of a soft tissue cutting deviceaccording to a third embodiment.

FIG. 15 illustrates a perspective view of a distal end of a soft tissuecutting device according to a third embodiment.

FIG. 16 illustrates a top view of a distal end of a soft tissue cuttingdevice according to a third embodiment.

FIG. 17 illustrates a perspective view of a blade activation assembly ofa soft tissue cutting device according to a third embodiment.

FIG. 18 illustrates another perspective view of a blade activationassembly of a soft tissue cutting device according to a thirdembodiment.

FIG. 19 illustrates an exploded view of a blade activation assembly of asoft tissue cutting device according to a third embodiment.

FIG. 20 illustrates a side view of a blade working end of a soft tissuecutting device according to a third embodiment.

FIG. 21 illustrates a perspective view of a blade working end of a softtissue cutting device according to a third embodiment.

FIG. 22 illustrates a side cross-section view of a shaft of a softtissue cutting device according to a third embodiment.

FIG. 22 illustrates a side cross-section view of a shaft at a distal endof a soft tissue cutting device according to a third embodiment.

FIG. 23 illustrates a side cross-section view of a shaft at a distal endof a soft tissue cutting device according to a third embodiment, whereinthe device is in first inactive position.

FIG. 24 illustrates a side cross-section view of a shaft at a distal endof a soft tissue cutting device according to a third embodiment, whereinthe device is in an active position.

FIG. 25 illustrates a side cross-section view of a shaft at a distal endof a soft tissue cutting device according to a third embodiment, whereinthe device is also in an active position.

FIG. 26 illustrates a side cross-section view of a shaft at a distal endof a soft tissue cutting device according to a third embodiment, whereinthe device is in a second inactive position.

FIG. 27 illustrates a perspective view of an inflation assembly of asoft tissue cutting device according to a third embodiment.

FIG. 28 illustrates a perspective view of a soft tissue cutting deviceaccording to a fourth embodiment.

FIG. 29 illustrates a perspective view of an inflation assembly of asoft tissue cutting device according to a fourth embodiment.

FIG. 30 illustrates a perspective view of a syringe activation assemblyof a soft tissue cutting device according to a fourth embodiment.

FIG. 31 illustrates another perspective view of a syringe activationassembly of a soft tissue cutting device according to a fourthembodiment.

FIG. 32 illustrates a side view of a syringe activation assembly of asoft tissue cutting device according to a fourth embodiment.

DETAILED DESCRIPTION

Certain embodiments of the invention provide a soft tissue cuttingdevice. The device includes a proximal end and a distal end. Theproximal end is configured to enable an operator to control variousfunctions on the distal end. The distal end is configured to performvarious functions, including cutting soft tissue in a body. The softtissue cutting device can be used to cut any desired soft tissue in thebody. In certain embodiments, the soft tissue cutting device is atransverse carpal ligament cutting device that cuts a transverse carpalligament in a carpal tunnel region.

The device includes a proximal end. The proximal end includes one ormore controls that control various functions on the distal end. Forexample, in some embodiments, the controls activate movement of a blade.In other embodiments, the controls activate inflating and deflating ofballoons. In yet other embodiments, the controls activate suctionthrough a passage.

In some embodiments, the proximal end includes a single-hand handpiece.The single-hand handpiece has a configuration that allows an operator tooperate the device using a single hand only. In some embodiments, thesingle-hand handpiece is configured as a gun-like handpiece. In somecases, the single-hand handpiece is a gun-like handpiece that includesthe one or more controls in a trigger area such that the operator cangrip the handpiece while operating the one or more controls withfingers. In other embodiments, the single-hand handpiece is configuredas a handle. In some cases, the single-hand handpiece is a handle thatincludes one or more controls in a thumb area such that the operator canuse a thumb to operate one or more controls. In yet other embodiments,the single-hand handle also includes one or more clamp-like controls inan area such that the operator can use a hand to clamp the controls. Insome embodiments, the single-hand handpiece is a handle that includesone or more controls on an inferior position of the handle such that theoperator can use a finger to operate one or more controls. However,skilled artisans will understand that the single-hand handpiece ismerely one embodiment of the present invention and is not required.Alternately, two hands or even two operators can operate the presentdevice.

The handpiece is coupled to a shaft that extends distally towards adistal end. The handpiece can be coupled to the shaft using a variety ofdifferent configurations. In some cases, the handpiece and shaft have apermanent junction. For example, the handpiece and shaft can have a setangular junction or a set straight junction. In other cases, thehandpiece and shaft have an adjustable junction that can be adjusted toaccommodate operator preference. In other cases, the handpiece and shafthave a rotatable junction that can be rotated to accommodate operatorpreference. For example, the handpiece and shaft can have a junctionthat is adjustable in length or angulation or rotation. In yet othercases, the handpiece and the shaft can have a removable junction so thatthe handpiece and the shaft are removable from one another.

The shaft has any desired cross-section shape. In some cases, the shafthas a circular cross-section shape. In other cases, the shaft has anon-circular cross section shape. For example, in some cases, the shafthas a squared cross section shape, rectangular cross section shape orsquared with round edges cross section shape.

As the shaft extends from the proximal end towards the distal end, itcan maintain the same cross-section shape or it can assume a differentcross-section shape. For example, in some cases, as the shaft extendsfrom the proximal end to the distal end, it maintains a circularcross-section. In other cases, as the shaft extends from the proximalend to the distal end, it changes from a circular cross-section to anon-circular cross section. In yet other cases, as the shaft extendsfrom the proximal end to the distal end, it maintains a non-circularcross section. In further cases, as the shaft extends from the proximalend to the distal end, it changes from a non-circular cross-section to acircular cross-section.

The shaft can also be provided as a single piece or as a plurality ofdifferent pieces. In some cases, the shaft extends from the proximal endto the distal end as a single piece. In other cases, the shaft extendsfrom the proximal end to the distal end as a plurality of piece. Theshaft is also formed of any desired medically acceptable material.

The shaft also has any desired size that is suitable for the medicalprocedure being performed. As the shaft extends from the proximal end tothe distal end, it can maintain the same diameter or it can assume adifferent diameter. In some cases, as the shaft extends from theproximal end to the distal end, it increases in diameter. In othercases, as the shaft extends from the proximal end to the distal end, itincreases in diameter.

The device also includes a distal end. The distal end is the working endthat inserts into the body region of a patient. The distal end includesthe shaft, a tip, a shaft opening, a blade, and one or more radiallyexpanding balloons. In some cases, the distal end also includes one ormore suction openings.

The shaft at the distal end has a size and cross-section shape that issuitable for being inserted into the body region of interest. The shaftextends longitudinally along a longitudinal axis. The shaft also has atop surface, side surfaces and a bottom surface. Each of the topsurface, side surfaces, and bottom surface can be made up of a singlewall or a plurality of walls. Additionally, each wall can be a straightwall or a curved wall. In some cases, the shaft is circular, such thatthe top quarter of the circle forms the top surface, the bottom quarterof the circle forms the bottom surface, and the remaining quarters formthe side surfaces. In other cases, the shaft is non-circular. The shaftalso has a surface that is destined to be positioned adjacent (or evenin direct contact with) the soft tissue being cut. In some cases, thetop surface is the surface destined to be positioned adjacent the softtissue.

The distal end also includes a tip. The tip is the distal-most end ofthe device and is positioned distally to the shaft. In some cases, thetip is an extension of the shaft. In other cases, the tip is a separatepiece that is positioned on the distal end of the shaft. The tip canhave any size or shape that guides the distal end to the body region. Insome embodiments, the tip has a rounded configuration, ovoidconfiguration, pointed configuration or conical configuration. In someembodiments, the tip is an echogenic tip and includes an ultrasoundprobe, camera or one or more optical fiber elements to transmit light toor from the distal region of the tip to the proximal portion of thedevice and is sized and shaped to house an ultrasound probe, camera orone or more optical fiber elements.

The shaft also includes a shaft opening. The shaft opening extends alonga longitudinal axis for a distance longitudinally along the shaft. Theshaft opening also extends along the shaft surface that is destined tobe positioned adjacent to or in direct contact with the soft tissuebeing cut. In some embodiments, the shaft opening extends longitudinallyalong the top surface and two side surfaces, so that the shaft openingis open superiorly, medially and laterally. This results in an “open”shaft opening. In other embodiments, the shaft opening extendslongitudinally only along the top surface, so that the shaft opening isonly open superiorly. This results in a “closed” shaft opening.

The shaft also houses a blade. The blade includes a working end that hasa cutting edge that is configured to cut the soft tissue. The cuttingedge can have any desired configuration that cuts soft tissue. In somecases, the cutting edge has a sharp straight edge. In other cases, thecutting edge has a sharp curved edge. In yet other cases, the cuttingedge has an angulated, toothed or sawed edge. The cutting edge extendsthrough the shaft opening when the device is in an active position andis protected within the shaft when the device is in an inactiveposition.

The cutting edge can also be positioned on any surface of the blade. Insome cases, the blade working end is linear and the cutting edge isprovided on a distal edge. In other cases, the blade working end islinear and the cutting edge is provided on a top edge. In other cases,the blade working end is configured as a hook and the cutting edge isprovided on an interior surface of the hook. In other cases, the bladehas two cutting surfaces allowing the blade to cut when pushed or pulledthrough soft tissue.

The blade is also movable with respect to the shaft using any number ofdifferent mechanisms. In some cases, the blade is movable by inflatingand deflating a blade balloon elevator. The blade balloon elevatorraises the blade out of the shaft and lowers the blade back into theshaft. In other cases, the blade is movable by moving the blade along ablade guideway. The blade guideway can also have a number of differentconfigurations. For example, in some cases, the blade guideway is asubstantially flat guide rail. In other cases, the blade guidewayincludes one or more ramps or inclines.

In other cases, the blade guideway has an adjustable height, allowing anoperator to increase or decrease cutting depths. Different patients havedifferent transverse carpal tunnel thicknesses and an adjustable bladeguideway allows an operator to adjust for these different thicknesses.The blade guideway height can be adjusted using any desired adjustmentmechanism. In certain cases, the blade guideway height is adjusted bychanging the angle of the ramps or inclines. In other cases, the bladeguideway height is adjusted using a balloon elevator.

The shaft also includes one or more balloons that expand radiallyoutwardly from the shaft. The balloons serve a number of differentpurposes. First, the balloons help to anchor the device within the bodyregion to provide stability during cutting of the soft tissue. Also, theballoons help to push nearby at-risk structures away from the deviceduring cutting. This helps to ensure that only the desired soft tissueis cut and that nearby at-risk structures are not cut.

The shaft can have any desired number of radially-expanding balloons. Insome cases, the shaft includes a lateral balloon that expands radiallyoutwardly from one of the two side walls. In other cases, the shaftincludes a dorsal balloon that expands radially outwardly from thebottom wall. Skilled artisans will understand that the shaft can haveany desired number of lateral and/or dorsal balloons.

In some embodiments, the distal tip includes one or more balloons thatexpand radially outward from the distal tip. Like the shaft, the distaltip can include any desired number of radially-expanding balloons. Insome cases, the distal tip includes a dorsal balloon that expandsradially outward from a bottom surface of the tip. These balloons servethe same purposes as the balloons that expand from the shaft.

When inflated, the balloons can have any desired configuration. In somecases, the balloons have a spherical configuration. In other cases, theballoons have an oval configuration. In yet other cases, the balloonshave a bilobular configuration.

The balloons can also be inflated and deflated using a number ofdifferent techniques. Generally, an inflation device supplies inflationmaterial to inflate the balloons and removes inflation material todeflate the balloons. The inflation material can be a gas (e.g., air) ora liquid or fluid (e.g., water or saline). The balloons can also inflateto a desired size selected to accommodate the patient body area ofinterest. For example, in some cases, the balloons can be provided witha specific size such that when they are fully inflated, they have aspecific inflated size. In other cases, the balloons can have a standardsize but can be partially inflated or fully inflated to have a varietyof different inflated sizes. In some cases, the balloon inflation can begraded to allow the operator to choose a particular balloon diameter. Incertain cases, the balloon inflation can be pressure dependent, suchthat the balloon manually or automatically inflates until a specificpressure is exerted on the balloon surface.

The inflation device supplies inflation material to the balloons usingany desired arrangement. In some cases, the shaft includes one or moreconduits operably coupled to both the balloons and the inflation deviceto deliver and remove gas/fluid to and from the balloons. In some cases,a single conduit is used to deliver and remove gas/fluid to and from theballoons. In other cases, a plurality of conduits can be used. In oneexample, a first conduit can deliver and remove gas/fluid to and from afirst balloon while a second conduit can deliver and remove gas/fluid toand from a second balloon. In another example, a first conduit candeliver gas/fluid to all of the balloons while a second conduit canremove gas/fluid from all of the balloons. Skilled artisans willunderstand that any arrangement of conduits can be used.

In some embodiments, the distal end also includes a plurality of suctionopenings. In some cases, the suction openings can be provided along theshaft surface that is destined to be positioned adjacent to or in directcontact with the soft tissue being cut. In many cases, the suctionopenings are provided along a top surface of the shaft. The suctionopenings can have any desired configuration. In some cases, the suctionopenings are circular holes. In other cases, the suction openings areslots. In yet other cases, the suction openings are provided as a singleelongated slot that extends along a shaft longitudinal axis.

Suction is applied to the suction openings to suck air through thesuction openings. This causes soft tissue near the suction openings tomove closer to the surface. Suction can be applied to the suctionopenings using any desired mechanism. In some cases, the shaft includesone or more conduits operably coupled to the suction openings to applysuction to the suction openings. In some cases, a single conduit is usedto apply suction to the suction openings. In other cases, a plurality ofconduits can be used. For example, a first conduit can apply suction tosome of the suction openings and a second conduit can apply suction toother of the suction openings. Skilled artisans will understand that anyarrangement of conduits can be used.

In some embodiments, the distal tip includes a portion that expands andcontracts so the tip can be inserted into the body with a smallercross-section and then expanded once in the body to a largercross-section. In some cases, the portion that expands and contracts isan outer shell provided on the distal tip. For example, the outer shellcan be provided along a portion of the shaft (or the entire shaft) toexpand radially outward when positioned in the body to create a greaterdistance between the central/ventral portion of the device when theknife is exposed during activation. Such an outer shell provides evenfurther protection to the body structures near the tissue being cut. Theouter shell can expand and contract using any known mechanism. In somecases, the outer shell includes a firm material. In other cases, theouter shell includes a malleable material. Mechanisms thatexpand/contract an outer shell include but are not limited to a coil,wedge and sleeve mechanism, a sliding wedge bolt mechanism, anexpansion-shell bolt mechanism, slot and wedge bolt mechanism, and aballoon expander/contractor mechanism. Skilled artisans will alsounderstand that any number of outer shells can be provided on the distaltip.

Certain exemplary embodiments of a transverse carpal ligament cuttingdevice 10 will now be described with reference to the Figures. FIGS. 1-7illustrate a transverse carpal ligament cutting device 10 according toan embodiment. The device 10 has a proximal end 12 and a distal end 14.The proximal end 12 can have any configuration to enable an operator tocontrol various functions on the distal end 14. In some cases, theproximal end 12 includes a single-hand handpiece according to anydesired configuration. The distal end 14 is configured to performvarious functions, including cutting a transverse carpal ligament in acarpal tunnel region.

FIG. 1 illustrates a side view of a proximal end 12 according to anembodiment. As shown in FIG. 1, the proximal end 12 includes asingle-hand handpiece 16. The single-hand handpiece 16 has aconfiguration that allows an operator to operate the device 10 using asingle hand only. The handpiece 16 can have any desired handpiececonfiguration. In FIG. 1, the handpiece is configured as a gun-likehandpiece. However, skilled artisans will understand that the handpiececan instead have any other embodiment described herein for a handpiece.For example, the handpiece can instead be configured as a handle 216 asshown in any of FIGS. 14, 28 and 29.

In FIG. 1, the handpiece 16 is configured as a gun-like handpiece thatincludes the one or more controls 18 in a trigger area such that theoperator can grip the handpiece 16 while operating the one or morecontrols with fingers. For example, in some embodiments, the controls 18activate movement of a blade. In other embodiments, the controls 18activate inflating and deflating of balloons. In yet other embodiments,the controls 18 activate suction through a passage.

The handpiece 16 is coupled to a shaft 20 that extends distally towardsa distal end. The handpiece 16 can be coupled to the shaft 20 using avariety of different configurations. In some cases, the handpiece 16 andshaft 20 have a permanent junction. For example, the handpiece 16 andshaft 20 can have a set angular junction or a set straight junction. Inother cases, the handpiece 16 and shaft 20 have an adjustable junctionthat can be adjusted to accommodate operator preference. For example,the handpiece 16 and shaft 20 can have a junction that is adjustable inlength or angulation. In yet other cases, the handpiece 16 and the shaft20 can have a removable junction so that the handpiece 16 and the shaft20 are removable from one another.

The shaft 20 has any desired cross-section shape. As the shaft 20extends from the proximal end 12 towards the distal end 14, it canmaintain the same cross-section shape or it can assume a differentcross-section shape. In some cases, as the shaft 20 extends from theproximal end 12 to the distal end 14, it maintains a circularcross-section. In other cases, as the shaft 20 extends from the proximalend 12 to the distal end 14, it changes from a circular cross-section toa non-circular cross section. In yet other cases, as the shaft 20extends from the proximal end 12 to the distal end 14, it maintains anon-circular cross section. In further cases, as the shaft 20 extendsfrom the proximal end 12 to the distal end 14, it changes from anon-circular cross-section to a circular cross-section.

The shaft 20 can also be provided as a single piece or as a plurality ofdifferent pieces. In some cases, the shaft 20 extends from the proximalend 12 to the distal end 14 has a single piece. In other cases, theshaft 20 extends from the proximal end 12 to the distal end 14 as aplurality of pieces. The shaft 20 is also formed of any desiredmedically acceptable material.

The shaft 20 also has any desired size that is suitable for performing aCTR procedure. As the shaft 20 extends from the proximal end 12 to thedistal end 14, it can maintain the same diameter or it can assume adifferent diameter. In some cases, as the shaft 20 extends from theproximal end 12 to the distal end 14, it increases in diameter. In othercases, as the shaft 20 extends from the proximal end 12 to the distalend 14, it increases in diameter.

The device 10 includes a distal end 14 that is the working end thatinserts into the carpal tunnel region. FIGS. 2-7 illustrate views of adistal end 14 according to one embodiment. The distal end 14 includes ashaft 20, tip 22, a shaft opening 24, a blade 26, a blade guideway 28, ablade stop 30, a first lateral balloon 34 a and a second lateral balloon36 b. Each of these components work together to safely cut a transversecarpal ligament in a carpal tunnel region.

The distal end 14 includes a shaft 20 that has a size and cross-sectionshape that is suitable for being inserted into the carpal tunnel region.The shaft 20 extends longitudinally along a longitudinal axis “x.” Theshaft 20 has a top surface 40, side surfaces 42, 44, and a bottomsurface 46. In this first embodiment, the shaft 20 has a non-circularcross-section such that top surface 40 includes a single top wall, theside surfaces 42, 44 include two side walls, and the bottom surface 44includes three side walls. Of course, skilled artisans will understandthat the shaft 20 can include any other desired cross-section and thateach shaft surface can include any desired number of side walls.

The distal end 14 includes a tip 22. The tip 22 is the distal-most endof the device 10 and is positioned distally to the shaft 20. In somecases, the tip 22 is an extension of the shaft 20. In other cases, thetip 22 is a separate piece that is positioned on the distal end of theshaft. The tip 22 can have any size or shape that guides the distal end14 through the carpal tunnel area. In this first embodiment, the tip 22has a pointed configuration. Of course, the tip 22 can have any otherdesired configuration. In some embodiments, the tip 22 is an echogenictip to improve visualization. In some cases, the echogenic tip includesan ultrasound probe and is sized and shaped to house an ultrasoundprobe.

The shaft 20 also includes a shaft opening 24. The shaft opening 24 alsoextends for a distance longitudinally along the surface that is destinedto be positioned adjacent to or in direct contact with the transversecarpal tunnel ligament. In this first embodiment, as best shown in FIG.2, the shaft opening 24 extends along the top surface 40 and two sidesurfaces 42, 44 so that the shaft opening 24 is open superiorly,medially and laterally. This results in an “open” shaft opening 24.

The shaft 20 also houses a blade 26. The blade 26 includes a cuttingedge 32 that is configured to cut a transverse carpal ligament. In thisfirst embodiment, the cutting edge 32 is a distal most edge of the blade26. The cutting edge 32 can have any desired configuration that cuts atransverse carpal ligament. Here, the cutting edge 32 has a sharpangulated edge. However, this is not required and the cutting edge 32can have any other desired configuration.

The shaft 20 also includes a blade guideway 28 that guides movement ofthe blade 26. The blade guideway 28 can be configured as a guide rail oras a tunnel. In the illustrated embodiment, the blade guideway 28 isconfigured as a guide rail that extends in a direction parallel to thelongitudinal axis x. Also, the guide rail is a substantially flat guiderail. Additionally, the shaft 20 includes a blade stop 30 that stopsmovement of the blade 26. In some cases, the blade stop 30 is sized andshaped to receive the cutting edge 32.

The blade 26 moves longitudinally along the “x” axis along the guiderail 28 in a forward distal direction and backward proximal direction.As the blade 26 moves forward distally, the cutting edge 32 movestowards the blade stop 30. Likewise, as the blade 26 moves backwardproximally, the cutting edge 32 moves away from the blade stop 30. Theblade 26 can perform cutting as an operator moves the blade proximallyor distally or both.

The shaft 20 also includes one or more balloons that expand or inflateradially outwardly from the shaft 20. This first embodiment illustratestwo lateral balloons 34 a, 34 b. The balloons 34 a, 34 b inflate andexpand outward laterally from the shaft 20. Likewise, the balloons 34 a,34 b deflate and shrink inwardly toward the shaft 20. When inflated, theballoons 34 a, 34 b have a spherical, oval, bilobular or otherconfiguration. When deflated, the balloons 34 a, 34 b are generallyflush with the shaft 20.

Skilled artisans will understand that any number of radially expandingballoons can be used and be placed anywhere about the shaft 20 to securethe distal end 14 in position within the carpal tunnel region and toexpand the “safe zone.” As the radially expanding balloons inflate, theymove the flexor tendons, median nerve, and ulnar neurovascular bundleaway from the device 12, effectively increasing the “safe zone.” Thishelps to ensure that only the transverse carpal ligament is cut and thatnearby at-risk structures are not cut.

In some embodiments, the distal tip 22 includes one or more balloonsthat expand radially outward from the distal tip 22. The firstembodiment does not use such a distal tip balloon. However, skilledartisans will understand that such a distal tip balloon can be used toincrease the distal “safe zone” between the tip and the superficialpalmar arch and/or further pushes the tip superiorly (i.e. palmarly) toengage the distal end of the transverse carpal ligament.

The balloons 34 a, 34 b can also be inflated and deflated using a numberof different techniques. In some cases, an inflation device supplies aninflation material to the balloons. The inflation material can be a gas(e.g., air) or a fluid or liquid (e.g., water or saline).

The inflation device supplies inflation material to the balloons 34 a,34 b using any desired arrangement. In some cases, the shaft includesone or more conduits operably coupled to both the balloons and theinflation device to deliver and remove gas/fluid to and from theballoons. In the first embodiment, the shaft 20 includes a conduit 50that delivers and removes gas or fluid from the balloons 34 a, 34 b. Ofcourse, skilled artisans will understand that other conduit arrangementsand other mechanisms of inflating and deflating the balloons 34 a, 34 bcan be used.

The balloons 34 a, 34 b can be made expandable using any number ofdesired configurations. In some cases, the entire balloon is expandableand thus inflates and deflates. In other cases, only part of the balloonis expandable. For example, the balloon can have a fixed portion and anexpandable portion. The fixed portion can be the portion that directlyattaches to a conduit whereas the expandable portion does not directlyattach to a conduit and instead expands freely of the conduit.

The balloons 34 a, 34 b also inflate to a desired size selected toaccommodate the size of a patient's wrist (and thus the patient's carpaltunnel region). For example, in some cases, the balloons can be providedwith a specific size such that when they are fully inflated, they have aspecific inflated size. In one embodiment, each of the balloons 34 a, 34b inflate to a similar or same diameter (e.g., a diameter of about 1.5mm). In patients with larger wrists, larger balloons can be used. Inpatients with smaller wrists, smaller balloons can be used. In anotherembodiment one of the balloons 34 a, 34 b inflates to one size and theother inflates to a different size. In other cases, the balloons 34 a,34 b can have a standard size but can be partially inflated or fullyinflated to have a variety of different inflated sizes. In some cases,the balloon inflation can be graded to allow the operator to choose aparticular balloon diameter. In certain cases, the balloon inflation canbe pressure dependent, such that the balloon manually or automaticallyinflates until a specific pressure is exerted on the balloon surface.

FIGS. 2, 4 and 6 show the distal end 14 in an inactive position. In theinactive position, the blade 26 is positioned such that its cutting edge32 is protected within the shaft 20 and is positioned proximally fromthe “open” shaft opening 24. The balloons 34 a, 36 b are also deflated.In this inactive position, the blade 26 is not exposed and does not poseany risk to the operator or the patient. Thus, the operator inserts andremoves the distal end 14 into and from the carpal tunnel region when itis in the inactive position.

FIGS. 3, 5 and 7 show the distal end 14 in an active position. In theactive position, the blade 26 is positioned such that its cutting edge32 is within the shaft opening 24. In the active position, the blade 26is exposed and is able to cut the transverse carpal ligament. Theballoons 34 a, 34 b are also inflated to anchor the distal end 14 inposition within the body and to expand the “safe zone” while the blade26 performs cutting.

During use, an operator inserts the distal end in an inactive positioninto the carpal tunnel region so that the transverse carpal ligament ispositioned within the shaft opening 24 and the tip 22 is hooked around adistal end of the transverse carpal ligament. The operator thenactivates a control to cause the balloons 34 a, 34 b to inflate. Theinflated balloons 34 a, 34 b stabilize the distal end 14 in positionwithin the carpal tunnel region and expand the “safe zone.”

The operator next activates a control to cause the blade 26 cut thetransverse carpal ligament. In one embodiment, the operator moves theblade 26 backward distally along the guideway 28 so that its cuttingedge 32 moves backward away from the blade stop 30 and into the coveredshaft 20. As the blade 26 moves proximally, the cutting edge 32 cuts thetransverse carpal ligament that is positioned within the shaft opening24. Once the cutting edge 32 moves into the covered shaft 20, theligament is completely cut. The operator can repeat this process asnecessary.

In another embodiment, the operator activates a control to cause theblade 26 to move forward distally along the guideway 28 so that itscutting edge 32 moves toward the blade stop 30. As the blade 26 movesdistally, the cutting edge 32 cuts the transverse carpal ligament thatis positioned within the shaft opening 24. The blade stop 28 stops thecutting edge 32 from moving any further distally. Once the cutting edge32 engages the blade stop 30, the ligament is completely cut. Theoperator can then repeat this process as necessary.

Once the transverse carpal ligament has been cut and the blade 26 ismoved back into the covered shaft 20, the operator then activates acontrol to cause the balloons 34 a, 34 b to deflate. The distal end 14resumes an inactive position and the operator can then safely remove thedistal end 14 from the body.

FIGS. 8-13 illustrate views of a transverse carpal ligament cuttingdevice 100 according to another embodiment. The device 100 has aproximal end (not shown) and a distal end 114 that inserts into thecarpal tunnel region. The proximal end 12 includes a single-handhandpiece according to any desired configuration. The single-handhandpiece 16 has a configuration that allows an operator to operate thedevice 10 using a single hand only. Skilled artisans will understandthat the handpiece can have any of the embodiments described herein fora handpiece, including the handpiece shown in each of FIGS. 1, 14, 28and 29.

The proximal end is coupled to a shaft 120 that extends distally towardsa distal end 114. The shaft 120 can have any embodiment alreadydescribed for shaft 20. The proximal end can have any desiredconfiguration to allow an operator to control various functions on thedistal end 114. The distal end 114 includes a shaft 120, a tip 122, ashaft opening 124, a blade 126, an optional blade base plate 128, ablade elevator balloon 130, a first lateral balloon 134 a, a secondlateral balloon 134 b, a dorsal balloon 136 and a plurality of suctionholes 138. Each of these components work together to safely cut atransverse carpal ligament in a carpal tunnel region.

The distal end 114 includes a shaft 120 that has a size andcross-section shape that is suitable for being inserted into the carpaltunnel region. The shaft 210 extends longitudinally along a longitudinalaxis “x.” The shaft 120 has a top surface 140, side surfaces 142, 144,and a bottom surface 146. In this second embodiment, the shaft 120 has anon-circular cross-section such that top surface 140 includes a singletop wall and the side surfaces 142, 144 and the bottom surface 44includes a curved side wall. Of course, skilled artisans will understandthat the shaft 120 can include any other desired cross-section and thateach shaft surface can include any desired number of side walls.

The distal end 114 includes a tip 122. The tip 122 is the distal-mostend of the device 10 and is positioned distally to the shaft 120. Insome cases, the tip 122 is an extension of the shaft 120. In othercases, the tip 122 is a separate piece that is positioned on the distalend 114 of the shaft 120. The tip 122 can have any size or shape thatguides the distal end 114 through the carpal tunnel area. In this secondembodiment, the tip 122 has a conical configuration. Again, skilledartisans will understand that the tip 122 can have any other desiredconfiguration. In some embodiments, the tip 122 is an echogenic tip thatincludes an ultrasound probe and is sized and shaped to house anultrasound probe.

The shaft 120 also includes a shaft opening 124. The shaft opening 124also extends for a distance longitudinally along the “x” axis. The shaftopening 124 extends along a surface that is destined to be positioned indirect contact with the transverse carpal ligament. In this secondembodiment, the top surface 140 is the surface that is destined to bepositioned in direct contact with the transverse carpal ligament. Assuch, the shaft opening 124 extends along the top surface 140 only sothat the shaft opening 124 is only open superiorly. This results in a“closed” shaft opening 124.

The shaft 120 also houses a blade 126. The blade 126 includes a cuttingedge 132 that is configured to cut a carpal tunnel ligament. In thissecond embodiment, the cutting edge 132 is a top edge of the blade 126.The cutting edge 132 can have any desired configuration that cuts softtissue. Here, the cutting edge 132 has a sharp straight edge. Thecutting edge 132 can also have any desired length.

The shaft 120 also includes an optional blade base plate 128 thatsupports the blade 126. The blade base plate 128 attaches to the blade126 along a bottom edge of the blade. Also, a blade elevator balloon 130is positioned beneath the blade base plate 128. In some embodiments, theblade 126 is connected directly to the blade elevator balloon 130 (andthere is no blade base plate 128). The blade elevator balloon 130 canhave any desired configuration, such as a spherical or bilobularconfiguration.

When the blade elevator balloon 130 inflates, it expands upward, thusmoving the blade base plate 128 (if included) and the blade 126 upward.The top cutting edge 132 moves upward through the opening 124 and cutsthe overlying transverse carpal ligament. When the blade elevatorballoon 130 deflates, it shrinks downward, thus moving the blade baseplate 128 (if included) and the blade 126 downward until it is againprotected within the shaft 120. The blade elevator balloon 130 can haveany desired configuration and size so that it can move the base plate128 and/or the blade elevator balloon 130 upward and downward.

The shaft 120 also includes a conduit 152 that delivers and removes gasor fluid to and from the blade elevator balloon 130. Of course, skilledartisans will understand that other conduit arrangements and othermechanisms of inflating and deflating the blade elevator balloon 130 canbe used.

The blade 126 can be elevated to any desired degree. The degree ofelevation also determines the degree of cutting of the overlyingtransverse carpal ligament. An operator can vary and individualize thedegree of cutting of the transverse carpal ligament by varying thedegrees of the balloon elevator expansion 130 and thus the base plate128 elevation.

The distal end 114 also includes a first lateral balloon 134 a and asecond lateral balloon 134 b. The distal end 114 also includes a dorsalballoon 136. The balloons 134 a, 134 b, 136 inflate and expand outwardlaterally from the device 112. Likewise, the balloons 134 a, 134 b, 136deflate and shrink inwardly toward the device 112. When inflated, theballoons 134 a, 134 b, 136 have a spherical, oval, bilobular or otherconfiguration. When deflated, the balloons 134 a, 134 b, 136 aregenerally flush with the distal end 114.

This embodiment illustrates two lateral balloons and one dorsal balloon.However, skilled artisans will understand that any number of balloonscan be used and the balloons can be placed anywhere about the shaft tosecure the distal end 114 in position within the carpal tunnel regionand to expand the “safe zone.”

The balloons 134 a, 134 b, 136 also inflate to a desired size selectedto accommodate the size of a patient's wrist (and thus the patient'scarpal tunnel region). For example, in some cases, the balloons 134 a,134 b, 136 can be provided with a specific size such that when they arefully inflated, they have a specific inflated size. In one embodiment,each of the balloons 134 a, 134 b, 136 inflate to a similar or samediameter (e.g., a diameter of about 1.5 mm). In patients with largerwrists, larger balloons can be used. In patients with smaller wrists,smaller balloons can be used. In another embodiment one of the balloons134 a, 134 b, 136 inflates to one size and another inflates to adifferent size. In other cases, the balloons 134 a, 134 b, 136 can havea standard size but can be partially inflated or fully inflated to havea variety of different inflated sizes. In some cases, the ballooninflation can be graded to allow the operator to choose a particularballoon diameter. In certain cases, the balloon inflation can bepressure dependent, such that the balloon manually or automaticallyinflates until a specific pressure is exerted on the balloon surface.

The shaft 120 also includes a conduit 150 that delivers and removes gasor fluid from the balloons 134 a, 134 b, 136. An inflation device (notshown) supplies inflation material such as gas, fluid, water or air tothe conduit 150. The inflation device also retracts inflation materialfrom the balloons 134 a, 134 b, 136 back through the conduit 150 andback into the inflation device. Of course, skilled artisans willunderstand that other conduit arrangements and other mechanisms ofinflating and deflating the balloons 134 a, 134 b, 136 can be used. Forexample, in some cases, a separate conduit can connect each balloon toan inflation device. Here then, each the balloons 134 a, 134 b, 136would be connected to an inflation device via its own conduit.

The shaft 120 further includes a plurality of suction openings 138. Insome cases, the suction openings 138 can be provided along a shaftsurface that is destined to be positioned in direct contact with thetransverse carpal ligament. In the second embodiment, the top surface144 is the surface that is destined to be positioned in direct contactwith the transverse carpal ligament. As such, the suction openings 138can be provided along the top surface 144.

The suction openings 138 can have any desired configuration. In thesecond embodiment, the suction openings 138 are circular holes. Ofcourse, the suction openings 138 can have any other desired shapes suchas a plurality of slots or a single slot.

Suction is applied to the suction openings 138 to suck air through thesuction openings 138. This causes the transverse carpal ligament to movecloser to the top surface 144. Suction can be applied to the suctionopenings 138 using any desired mechanism. In some cases, the shaft 120includes a vacuum conduit 154 that sucks air through the suctionopenings 138. Skilled artisans will understand that one or more conduitscan be operably coupled to the suction openings to apply suction to thesuction openings 138. In some cases, a single conduit is used to applysuction to the suction openings 138. In other cases, a plurality ofconduits can be used. For example, a first conduit can apply suction tosome of the suction openings 138 and a second conduit can apply suctionto other of the suction openings 138. Skilled artisans will understandthat any arrangement of conduits can be used.

FIGS. 8, 10 and 12 show the distal end 114 in an inactive position. Inthe inactive position, the blade 126 is positioned such that its cuttingedge 132 is protected within the shaft 120. The balloons 130, 134 a, 134b, 136 are also deflated. In this inactive position, the blade 126 isnot exposed and does not pose any risk to the operator or the patient.Thus, the operator inserts and removes the distal end 114 into and fromthe carpal tunnel region when it is in the inactive position.

FIGS. 9, 11 and 13 show the distal end 114 in an active position. In theactive position, blade elevator balloon 130 is inflated and the blade126 is positioned such that its top cutting edge 132 extends through thesuperior shaft opening 124 and is exposed. In the active position, theblade 126 is exposed and is able to cut the transverse carpal ligament.The balloons 134 a, 134 b, 136 are also inflated to anchor the distalend 114 in position within the body and to expand the patient's safezone while the blade 126 performs cutting.

During use, an operator inserts the distal end 114 into a carpal tunnelregion such that the transverse carpal ligament is positioned adjacentthe working side 124 of the distal end 114. The operator then activatesa control to cause the balloons 134 a, 134 b, 136 to inflate and toexpand the safe zone within the carpal tunnel region. The operator nextactivates a control to suck air through the suction openings 138. Again,this in turn pulls the transverse carpal ligament towards the topsurface 140 to optimize contact between the top surface 140 and thetransverse carpal ligament.

The operator next activates a control to cause the balloon elevator toexpand so that the cutting edge 132 moves upward through the opening 124and cuts into the transverse carpal ligament. The depth of the cut canbe varied by modulating the extent of the blade elevator balloon 130inflation. In general, 2-3 mm of upward displacement is sufficient tocut the transverse carpal ligament. The ligament may be completely cutby the upward motion, or may be partially cut/fenestrated by reducingthe amount of blade elevation and/or using a blade having a serrated orsaw tooth cutting edge 132.

In some cases, once the cutting edge 132 is engaged with the transversecarpal ligament, the operator can manually move the entire device 12forward distally and backward proximally to impart a sawing motion, asnecessary or desired. However, the amplitude of anticipated operatormotion should be small given the stabilizing properties of the device.

Once the transverse carpal ligament is cut, the operator activatescontrols to stop the suction through the suction holes and to deflateall the balloons 134 a, 134 b, 136. This causes the blade 126 to moveback downward into the shaft 120. The operator then safely removes thedistal end 114 from the body.

FIGS. 14-27 illustrate views of a transverse carpal ligament cuttingdevice 200 according to another embodiment. Referring to FIG. 14, thedevice 200 has a proximal end 212 and a distal end 214. The proximal end212 includes a handle 216. The distal end 214 includes a shaft 220 thatinserts into the carpal tunnel region. The handle 216 includes a bladeactivation assembly 222. The device 200 also includes an inflationassembly 218 coupled to the handle 216. The inflation assembly 218 andblade activation assembly 222 each control various functions of theshaft 220 at the distal end 214.

Referring to FIGS. 15-16, the distal end 214 includes a shaft 220, a tip224, a shaft opening 226, a blade 228, a first balloon 234 a and asecond balloon 234 b. The shaft 220 can also include a shaft cover 236.The shaft 220 also has a size and cross-section shape that is suitablefor being inserted into the carpal tunnel region. The shaft 220 extendslongitudinally along a longitudinal axis “x.” The shaft 220 has a topsurface 238, side surfaces 240 a, 240 b, and a bottom surface 242. Theshaft 220 can also have any embodiment described for shaft 20 or shaft120.

The distal end 214 includes a tip 224. The tip 224 is the distal-mostend of the device 200 and is positioned distally to the shaft 220. Insome cases, the tip 224 is an extension of the shaft 220. In othercases, the tip 224 is a separate piece that is positioned on the distalend of the shaft 220. The tip 224 can have any size or shape that guidesthe distal end 214 through the carpal tunnel area. In this embodiment,the tip 224 has a rounded configuration. Of course, the tip 224 can haveany other desired configuration. In some embodiments, the tip 224 is anechogenic tip that includes an ultrasound probe and is sized and shapedto house an ultrasound probe.

The shaft 220 also includes a shaft opening 226. The shaft opening 226also extends for a distance longitudinally along the surface that isdestined to be positioned adjacent to or in direct contact with thetransverse carpal tunnel ligament. In this embodiment, as shown in FIGS.15-16, the shaft opening 226 extends along the top surface 238 so thatthe shaft opening 226 is open superiorly.

The shaft 220 also houses a blade 228. Referring to FIGS. 17-19, theblade 228 includes a blade shaft 244 and a blade working end 246. Theblade shaft 244 engages with a blade activation assembly 222 to move theblade 228 forward and backward. The blade working end 246 is the endthat is configured to cut a transverse carpal ligament.

FIGS. 20-21 illustrate a blade working end 246 according to anembodiment. In this embodiment, the blade working end 246 is configuredas a hook. The hook includes an outer surface 248 and an inner surface250 that come together at a point 252. The inner surface 250 includes acutting edge 254. The cutting edge 254 thus includes a non-linear edge.Instead the cutting edge 254 includes a curved edge. In otherembodiments, the blade working end is configured as an angled bladehaving an outer surface and an inner surface. The inner surface includesan angled cutting edge.

The outer surface 248 does not include a cutting edge. Rather, at leastpart of the entire outer surface 248 (or substantially the entire outersurface 248 or the entire outer surface 248) is a dull and/or bluntsurface that would not cut body tissue. Likewise, the point 252 isconfigured as a tip that would not cut body tissue. In other words, thepoint 252 does not have any exposed sharp edges that would cut bodytissue. In some cases, the point 252 is a blunt point and/or a dullpoint and/or a rounded point.

The blade working end 246 also includes a blade pin 256. The blade pin256 is positioned on the blade working end 246 such that the pin 256moves along a blade guideway 258 (described below). In some embodiments,the blade pin 256 is positioned along the outer surface 248. The bladepin 256 can be mechanically or weldedly attached to the blade workingend 246. In other embodiments, the blade pin 256 is provided as part ofor integral to the blade working end 246 and is not a separate piece.

Referring to FIG. 22, the shaft 220 also includes a blade guideway 258that guides movement of the blade 228. An operator moves the blade 228forward and backward along the blade guideway 258. The blade guideway258 can be any guide, groove, track or tunnel that guides the forwardand rearward movement of the blade 228. The blade guideway 258 includesa distal guideway end 260, a distal incline 262, a plateau 264, aproximal incline 266 and a proximal guideway end 268. As shown, theplateau 264 is positioned between two inclines 262, 266. Also, thedistal incline 262 is positioned between the distal guideway end 260 andthe plateau 264. Further, the proximal incline 266 is positioned betweenthe proximal guideway end 268 and the plateau 264. The distal incline262 and proximal incline 266 can be configured as inclines or rampshaving any desired slope. In some cases, the distal incline 262 andproximal incline 266 each have a slope angle of between 0° and 90°. Incertain cases, the distal incline 262 and proximal incline 266 each havea slope angle of between 30° and 60°.

The blade 228 includes a blade pin 256 that moves within or along theblade guideway 258. FIGS. 23-26 illustrate a path of the blade pin 256as it moves along the blade guideway 258. In FIG. 23, the blade pin 256is positioned at the distal guideway end 260. As shown in FIG. 24, theoperator moves the blade 228 backward to move the blade pin 256 up thedistal incline 262. As shown in FIG. 25, the operator continues to movethe blade 228 backward so that the blade pin 256 moves backward alongthe plateau 264. Once the blade pin 256 reaches the proximal incline266, it moves down the proximal incline 266 until it reaches theproximal guideway end 268, as shown in FIG. 26.

When the blade pin 256 is positioned at the distal guideway end 260, asshown in FIG. 23, the cutting edge 254 of the blade 228 is housed withinthe shaft 220 and is not exposed through the shaft opening 226.Likewise, when the blade pin 256 is positioned at the proximal guidewayend 268, as shown in FIG. 26, the cutting edge 254 is housed within theshaft 220 and is not exposed through the shaft opening 226. When thecutting edge is housed within the shaft 220, the device 200 is in aninactive or protected position.

On the other hand, when the blade pin 256 is positioned along theplateau 264, as shown in FIGS. 24-25, the cutting edge 254 of the blade228 extends through the shaft opening 226 and is exposed. In this case,the device 200 is in an active position and is able to cut soft tissue.

Referring back to FIGS. 15-16, the shaft 220 also includes one or moreballoons that expand radially outwardly from the shaft 220. The balloonscan be positioned anywhere about the shaft 220 such that they expand thesafe zone of the carpal tunnel region. This embodiment illustrates twolateral balloons 234 a, 234 b that are positioned on sides 240 a, 240 bof the shaft 220. The balloons 234 a, 234 b inflate and expand outwardlaterally from the shaft 220. Likewise, the balloons 234 a, 234 bdeflate and shrink inwardly toward the shaft 220. When inflated, theballoons 234 a, 234 b have a spherical, oval, bilobular or otherconfiguration. When deflated, the balloons 234 a, 234 b can be generallyflush with the shaft 220.

The shaft 220 also optionally includes a first channel 230 a and asecond channel 230 b. The first lateral balloon 234 a can be positionedso that it lies within the first channel 230 a. Likewise, the secondlateral balloon 234 b can be positioned so that it lies within thesecond channel 230 b. The channels 230 a, 230 b can have any size andshape that accommodates the balloons 234 a, 234 b.

Skilled artisans will understand that any number of radially expandingballoons can be used and be placed anywhere about the shaft 220 tosecure the distal end 216 in position within the carpal tunnel regionand to expand the “safe zone.” As the radially expanding balloonsinflate, they move the flexor tendons, median nerve, and ulnarneurovascular bundle away from the device 200, effectively increasingthe “safe zone.” This helps to ensure that only the transverse carpalligament is cut and that nearby at-risk structures are not cut.

The device 200 also includes a blade activation assembly 222. FIGS.17-19 illustrate an embodiment of a blade activation assembly 222. Theblade activation assembly 222 includes a slider button 270, a firstplate 272, a second plate 274, a plate pin 276, a first screw 278 a, asecond screw 278 b, a blade latch 280, a blade latch pin 282 and a ball284. The slider button 270 is positioned on an external surface of thehandle 216. An operator engages the slider button 270 with a finger (forexample by engaging a thumb with the slider button 270). The operatorpulls the slider button 270, which allows the guide pin 256 to slideaway from the distal guideway 260 within the guideway incline 262 untilreaching the end point of the proximal guideway 268. The slider button270 can move in both forward and backward directions to move the blade228 forward and backward.

The device 200 also includes an inflation assembly 218. The inflationassembly 218 includes the first balloon 234 a, a first conduit 286 a,the second balloon 234 b, a second conduit 286 b, and an inflationdevice 288. The inflation device 288 can be provided inside of thehandle 216 and/or provided outside of the handle 216. FIG. 27illustrates an embodiment of an inflation assembly 288 that is providedoutside of the handle 216. Skilled artisans will also understand thatthe inflation assembly 218 described in this embodiment can also beincluded in any of the other device embodiments (e.g., device 10, 100)described herein.

The first conduit 286 a connects the first balloon 234 a to theinflation device 288. Likewise, the second conduit 286 b connects thesecond balloon 236 b to the inflation device 288. The inflation device288 supplies inflation material such as gas, fluid, water or air to eachthe first conduit 286 a and second conduit 286 b, which in turn supplythe inflation material to the first balloon 234 a and the second balloon234 b. The inflation material causes the first balloon 234 a and thesecond balloon 234 b to inflate. The inflation device 288 also retractsinflation material from the first balloon 234 a and second balloon 234 bback through the first conduit 286 a and second conduit 286 b and backinto the inflation device 288. Thus, the inflation device 288 inflatesand deflates the balloons 234 a, 234 b.

In some embodiments, the first conduit 286 a and the second conduit 286b directly connect to the inflation device 288. In other embodiments, apiping arrangement 290 is provided between the first conduit 286 a, thesecond conduit 286 b and the inflation device 288. For example, as shownin FIG. 27, each the first conduit 286 a and the second conduit 286 bconnect to a coupling 292. In some cases, the coupling 292 is a y-shapedcoupling that splits inflation material into the first conduit 286 a andsecond conduit 286 b when the material is moving towards the balloons234 a, 234 b. Likewise, the coupling 292 can combine inflation materialfrom the first conduit 286 a and the second conduit 286 b into a singleconduit 294 when the material is moving back towards the inflationdevice 288. Such a piping arrangement 290 can provide increasedefficiency of movement of the inflation material.

The first balloon 234 a connects to the first conduit 286 a and thesecond balloon connects 234 b to the second conduit 286 b. In someembodiments, the first balloon 234 a directly attaches to the firstconduit 286 a and the second balloon 234 b directly attaches to thesecond conduit 286 b, although this is not required. In certain cases,the first conduit 286 a is positioned inside of the first balloon 234 aand the second conduit 286 b is positioned inside of the second balloon234 b. Each conduit 286 a, 286 b includes a plurality of openings 202that open into the balloons 234 a, 234 b.

FIG. 15 illustrates one embodiment showing a conduit positioned insideof a balloon. In FIG. 15, the second conduit 286 b is shown positionedinside of the second balloon 234 b. The second conduit 286 b includes aplurality of openings 202 that open into the inside of the secondballoon 234 b. Inflation material moves in and out of these openings202. Although not seen in FIG. 15, the first balloon 234 a can connectto the first conduit 286 a in a similar or identical manner.

The balloons 234 a, 234 b can have any desired configuration that allowsthem to inflate and deflate. In some embodiments, the entire balloon isexpandable and thus inflates and deflates. In other embodiments, onlypart of the balloon is expandable. For example, the balloon can have afixed portion and an expandable portion. FIG. 15 illustrates anembodiment wherein the balloon 234 b has a fixed portion and anexpandable portion 206. The fixed portion 204 can be the portion thatdirectly attaches to conduit 286 b whereas the expandable portion 206does not directly attach to the conduit 286 b and instead expands freelyof the conduit 286 b.

The balloons 234 a, 234 b also inflate to a desired size selected toaccommodate the size of a patient's wrist (and thus the patient's carpaltunnel region). For example, in some cases, the balloons 234 a, 234 bcan be provided with a specific size such that when they are fullyinflated, they have a specific inflated size. In one embodiment, each ofthe balloons 234 a, 234 b inflate to a similar or same diameter (e.g., adiameter of about 1.5 mm). In patients with larger wrists, largerballoons can be used. In patients with smaller wrists, smaller balloonscan be used. In another embodiment one of the balloons 234 a, 234 binflates to one size and another inflates to a different size. In othercases, the balloons 234 a, 234 b can have a standard size but can bepartially inflated or fully inflated to have a variety of differentinflated sizes. In some cases, the balloon inflation can be graded toallow the operator to choose a particular balloon diameter. In certaincases, the balloon inflation can be pressure dependent, such that theballoon manually or automatically inflates until a specific pressure isexerted on the balloon surface.

The inflation device 288 can be any desired device known in the art thatholds inflation material and both pushes inflation material out of theinflation device 288 and pulls inflation material back into theinflation device 288. In FIG. 27, the inflation device 288 is a syringe232. Skilled artisans will understand that the illustrated syringe 232is merely one embodiment of an inflation device 288 and that otherdevices are suitable. Also, in the illustrated embodiment, the syringe232 is provided outside of the handle 216. However, skilled artisanswill understand that the syringe 232 can instead be provided inside ofthe handle 216. The syringe 232 can be provided by itself or as part ofa syringe control assembly (e.g., as a part of a syringe controlassembly 324 described with reference to FIGS. 28-32).

The syringe 232 includes a barrel 296 and a plunger 298. The syringe 232holds fluid inside of the barrel 296. When the operator desires toinflate the balloons 234 a, 234 b, he or she pushes the plunger 298 topush fluid into the piping arrangement 290 (or directly into theconduits 286 a, 286 b). The fluid moves into the conduits 286 a, 286 band exits through the openings 202 into the balloons 234 a, 234 b. Whenthe operator desires to deflate the balloons 234 a, 234 b, he or shepulls or retracts the plunger 298 to pull fluid back towards theinflation device 288. This causes fluid to move out of the balloons 234a, 234 b through the openings 290 and back into the conduits 286 a, 286b.

During use, an operator first obtains a device 200 that is in the firstinactive position. In the first inactive position, the device 200 hasits blade 228 positioned such that the blade pin 256 is positioned atthe distal guideway end 260 of the blade guideway 258 as shown in FIG.23. The cutting edge 254 is fully housed and protected within the shaft220 and the device 200 can be safely inserted into a carpal tunnelregion. The device 200 also has its balloons 234 a, 234 b in a deflatedconfiguration. The operator inserts the distal end 214 into a carpaltunnel region such that the transverse carpal ligament is positionedadjacent the top surface 238 of the shaft 220. The operator thenactivates a control to cause the balloons 234 a, 234 b inflate and toexpand the safe zone within the carpal tunnel region.

The operator next moves the slider button 270 backward to move the bladeworking end backward and up the distal incline 262 as shown in FIG. 24.Once the blade working end reaches the plateau as shown in FIG. 25, thecutting edge 254 is fully exposed and able to cut the transverse carpalligament. The operator continues to move the slider button 270 backwardto move the blade working end (and cutting edge) backward along theplateau 264. As the cutting edge 254 moves backward, it cuts thetransverse carpal ligament.

The operator continues to move the slider button 270 backward to movethe blade working end backward and down the proximal incline 266. Theblade 228 stops moving backward once the blade pin 256 reaches theproximal guideway end 268 as shown in FIG. 26. Once the blade pin 256reaches the proximal guideway end 268, the transverse carpal ligament iscut and the device 200 is in the second inactive position. The operatorthen activates a control to cause the balloons 234 a, 234 b to deflate.In this second inaction position, the device 200 has its blade 228positioned such that the blade pin 256 is positioned at the proximalguideway end 268 of the blade guideway 258 as shown in FIG. 23. Thecutting edge 254 is fully housed and protected within the shaft 220 andthe device 200 can be safely removed from the body.

In certain embodiments, the handle also houses the syringe. In suchcases, the syringe includes an actuator or control positioned outside ofthe handle that controls functions of the syringe. For example, thecontrol can be a lever, slider button, push button and/or clamp. In somecases, the control is another slider button positioned on an externalsurface of the handle. The slider button can be coupled to a plunger tocontrol movement of the plunger. In some cases, the slider button isdirectly connected to the plunger. In other cases, the control is aclamp. In such cases, the clamp can be coupled to a plunger to controlmovement of the plunger. When an operator desires to inflate theballoons, he or she slides the slider button forward (or compresses theclamp) to push the plunger and push fluid from the barrel into a pipingarrangement. When the operator desires to deflate the balloons, he orshe slides the slider button backward (or decompresses the clamp) toretract the plunger and retract fluid back into the barrel.

FIGS. 28-32 illustrate views of a transverse carpal ligament cuttingdevice 300 according to another embodiment. Referring to FIG. 28, thedevice 300 has a proximal end 312 and a distal end 314. The proximal end312 includes a handle 316. The distal end 314 includes a shaft thatinserts into the carpal tunnel region. The handle 316 includes a bladeactivation assembly 322. The device 300 also includes an inflationassembly 318 coupled to the handle 316. The inflation assembly 318 andblade activation assembly 322 each control various functions of theshaft at the distal end 314.

The soft tissue cutting device or transverse carpal ligament cuttingdevice 300 includes a distal end 314 including a shaft. In someembodiments, the distal end 314 can be in accordance with the distal end214 already described with reference to FIGS. 15-16 and 22-26. In suchcases, the distal end 314 includes one or more or all of the componentsand functions of distal end 214.

The device 300 also includes a blade activation assembly 322. In someembodiments, the blade activation assembly 322 can be in accordance withthe blade activation assembly 222 already described with reference toFIGS. 17-19. In such cases, blade activation assembly 322 includes oneor more or all of the components and functions of blade activationassembly 222. Likewise, the blade activation assembly 322 can include ablade in accordance with the blade 228 already described with referenceto FIGS. 17-19 and 20-21. In such cases, blade of device 300 includesone or more or all of the components and functions of blade 228.

The device 300 also includes an inflation assembly 318. The inflationassembly 318 includes one or more or all of the components and functionsalready described for the inflation assembly 218. For example, in FIG.29, the inflation assembly 318 is shown as including at least the firstballoon 234 a, a first conduit 286 a, the second balloon 234 b and asecond conduit 286 b.

The inflation assembly 318 includes an inflation device. In some cases,the inflation device includes a syringe 238 that is part of a syringecontrol assembly 324. FIGS. 29-31 illustrate a syringe control assembly324 according to one embodiment. The syringe control assembly 324includes a clamp 326, a syringe 328, a decompression mechanism 330 and acompression mechanism 332. Generally, when the operator desires toinflate the balloons 234 a, 234 b, he or she engages with the clamp 326to cause the decompression mechanism 330 push fluid into the conduits286 a, 286 b. When the operator desires to deflate the balloons 234 a,234 b, he or she reengages with the clamp 326 to cause the compressionmechanism 332 pull fluid back towards and into syringe 328. This causesfluid to move out of the balloons 234 a, 234 b and back into theconduits 286 a, 286 b.

The syringe 328 includes a barrel 334 and a plunger 336. The barrel 334moves forward distally and backward proximally with respect to theplunger 336. In some cases, the plunger 336 is fixed in position withinthe handle 316 and the barrel 334 moves forward distally and backwardproximally with respect to the fixed plunger 336.

In certain cases, the barrel 334 also includes a flange 338. The flange338 at least partially expands radially outward from the barrel 330. Insome cases, the flange 338 expands radially outwardly on a first sideand a second side such that there is a first flange portion 338 a on thefirst side and a second flange portion 338 b on the second side.

The syringe control assembly 324 includes a decompression mechanism 330.The clamp 326 is operably coupled to the decompression mechanism 330such that when the clamp 326 is engaged, the decompression mechanism 330causes the barrel 334 to move backward proximally with respect to theplunger 336. This causes the plunger 336 to move deeper into the barrel334, thus pushing fluid in the barrel 334 out of the syringe 328 andinto the balloon conduits. In some cases, the decompression mechanism330 is operably coupled to a barrel holder 340 to move the first flangeportion 338 a and/or the second flange portion 338 b forward distallyand backward proximally.

The syringe control assembly 324 also includes a compression mechanism332. The clamp 326 is operably connected to the compression mechanism332 such that when the clamp 326 is reengaged, the compression mechanism332 causes the barrel to move forward distally with respect to theplunger 336. This causes the plunger 336 to move out of the barrel 334such that it pulls fluid out of the balloon conduits and back into thebarrel 334. In some cases, the compression mechanism 332 is operablycoupled to a barrel plate 392 to move the first flange portion 338 aand/or the second flange portion 338 b forward distally and backwardproximally.

In some embodiments, as best illustrated in FIG. 31, the clamp 326includes a hand-engaging portion 350 and an arm-connecting portion 352.The arm-connecting portion 352 couples to an arm 354. The arm 354 inturn couples to a connector 356. In some cases, the arm 354 couples tothe arm-connecting portion 352 via a connection 358. Likewise, thearm-connecting portion 354 couples to the connector 356 via a connection360. Further, the connector 356 couples to the compression mechanism 332via a connection 364. In some cases, one or more or all of theconnections 358, 360, 364 are hinged connections.

The compression mechanism 332 includes a lumen 370, a spring 372 and acap 374. The lumen 370 includes a proximal end 376 and a distal end 378.The lumen 370 also includes an outer surface 380. The spring 372 iswound about the outer surface 380 of the lumen 370. A cap 374 ispositioned on the distal end 378 to secure the spring 372 in place onthe outer surface 380. Also, a barrel holder 340 is positioned on theproximal end 376, also securing the spring 372 in place.

The barrel holder 340 connects to the barrel 334. The barrel holder 340connects to the second flange portion 338 b. In some cases, the barrelholder 340 includes a groove 342 that retains the second flange portion338 b. The barrel holder 340 holds and moves the second flange portion338 b forward distally and resists movement backward proximally (thusmoving the barrel 334 forward distally and resisting movement of thebarrel 334 backward proximally).

The compression mechanism 332 also includes a piston 380, a lumen 382and a spring 384. The lumen 382 also includes a proximal end 386 and adistal end 388 and an outer surface 390. The spring 384 is positionedbetween the piston 380 and the proximal end 386 and is wound about theouter surface 390. A barrel plate 392 is also positioned at the proximalend 386 to secure the spring 384 in place.

The barrel plate 392 also connects to the barrel 334. In some cases, thebarrel plate 392 connects to the first flange portion 338 a. In somecases, the barrel plate 392 includes a groove 394 that receives thefirst flange portion 338 a. The barrel plate 392 holds and moves thefirst flange portion 338 a backward proximally (thus moving the barrel334 backward proximally).

An operator first compresses or clamps the hand-engaging portion 350 ofthe clamp 326, causing the arm-connecting portion 352 to move proximallyvia a pivot point within the arm-connecting portion 352 (not shown),which in turn pulls the arm 354 proximally. When the arm 354 movesproximally it acts on a lower portion of the connector 356 to move thelower portion proximally via a pivot point within the connector 356 (notshown). As the lower portion moves proximally, it causes the upperportion to move distally. The distal movement of the upper portion actson the compression mechanism 332. The flange connector 392 pushes theflange 338 a proximally, thereby compressing the syringe 324. Thedecompression mechanism 330 is also connected to the flange 338 b viathe barrel holder 340. The decompression mechanism 330 resistscompression of the syringe 324 via the spring 372.

During use, an operator first obtains a device 300 that is in a firstinactive position. In the first inactive position, the device 300 hasits blade 228 positioned such that the blade cutting edge is protectedwithin a shaft and the device 300 can be safely inserted into a carpaltunnel region. The device 300 also has its balloons in a deflatedconfiguration. The inactive position can be any inactive position of thedevices already described herein. The operator inserts the distal end314 into a carpal tunnel region and then engages the clamp 326, thusprompting the syringe control assembly 334 and causing the balloonsinflate and to expand the safe zone within the carpal tunnel region.Once cutting is completed, the operator reengages the clamp 326, thusprompting the syringe control assembly 324 to cause the balloons todeflate.

In some cases, the soft tissue cutting device also includes a safetymechanism. Such a safety mechanism can be provided in any of theembodiments already described. The safety mechanism prevents an operatorfrom operating the device to deflate the balloons while the blade isactive. In other words, the device has a locked position and an unlockedposition. In the locked position, the balloons cannot be deflated. Inthe unlocked position, the balloons can be inflated.

Also, in some cases, the soft tissue cutting device includes aninflation device that includes multiple inflation levels. For example,in certain cases, the syringe of any of the embodiments described is asyringe that includes multiple compression levels. For example, themultiple compression levels can include a first compression level (“x”PSI), a second compression level (“x+” PSI), a third compression level(“x++” PSI) and so on. In some cases, the multiple compression levelsalso include a decompression level.

Certain embodiments provide a soft tissue cutting method. The method canuse any of the soft issue cutting devices described herein. In oneembodiment, the method includes steps of providing a soft-tissue cuttingdevice comprising: (a) a shaft, (b) a shaft opening in the shaft, (c) ablade that extends through and withdraws from the shaft opening, (d) oneor more balloons coupled to the shaft that expand radially outward fromthe shaft. The method can further include steps of advancing thesoft-tissue cutting device to a body region, expanding the one or moreballoons radially outward and extending the blade through the shaftopening to cut the soft tissue.

Other embodiments provide a method of cutting a transverse carpalligament. The method can use any of the transverse carpal ligamentcutting devices described herein. In one embodiment, the method includesthe steps of providing a cutting device having an inactive position andan active position, wherein in the inactive position the device includesan unexposed blade and one or more deflated balloons and in the activeposition the device includes an exposed blade and one or more inflatedradially-expanding balloons, advancing the device to a carpal tunnelregion while the device is in the inactive position, and cutting atransverse carpal ligament while the device is in the active position.

While different embodiments of a soft tissue cutting device aredescribed, skill artisans will understand that any of the features ofone embodiment can be incorporated into the other embodiments. Anycombination of the features described in any of the embodiments can beincluded in the soft tissue cutting device and are within the scope ofthe invention.

The invention claimed is:
 1. A soft tissue cutting device, comprising:(a) a shaft having a top surface, two side surfaces and a bottomsurface, wherein the shaft extends along a longitudinal axis; (b) ashaft opening that extends for a distance along the longitudinal axisand extends longitudinally along the top surface of the shaft; (c) ablade that extends through and withdraws from the shaft opening, theblade having a top cutting edge that extends in a direction parallel tothe longitudinal axis; and (d) one or more balloons coupled to the shaftthat expand radially outwardly from the shaft, wherein the top cuttingedge is housed within the shaft when the soft tissue cutting device isin an inactive position, and the top cutting edge extends upwardlythrough the shaft opening when the soft tissue cutting device is in anactive position, wherein the blade is coupled to a blade elevatorballoon, wherein the blade elevator balloon inflates to extend the topcutting edge upward through the shaft opening and deflates to retractthe top cutting edge downward through the shaft opening, and wherein theblade elevator balloon is configured to receive gas or fluid forinflating the blade elevator balloon so as to extend the top cuttingedge upward through the shaft opening.
 2. The soft tissue cutting deviceof claim 1 wherein the one or more balloons includes a lateral balloonthat expands radially outwardly from one of the two side surfaces. 3.The soft tissue cutting device of claim 1 wherein the one or moreballoons includes a dorsal balloon that expands radially outwardly fromthe bottom surface.
 4. The soft tissue cutting device of claim 1 whereinthe one or more balloons includes a first lateral balloon that expandsradially outwardly from one of the two side surfaces, a second lateralballoon that expands radially outwardly from another of the two sidesurfaces, and a dorsal balloon that expands radially outwardly from thebottom surface.
 5. The soft tissue cutting device of claim 1 wherein thesoft tissue cutting device includes a proximal end configured as asingle-hand handpiece including one or more controls for activatingmovement of the blade and inflation and deflation of the one or moreballoons, wherein the one or more controls are configured to beactivated using a single hand.
 6. The soft tissue cutting device ofclaim 1 wherein the top surface includes a plurality of suctionopenings.
 7. The soft tissue cutting device of claim 1 wherein thesoft-tissue cutting device is a transverse carpal ligament cuttingdevice.
 8. The soft tissue cutting device of claim 1 wherein the bladeelevator balloon is configured to provide uniform elevation of the bladealong a longitudinal extent of the blade.
 9. The soft tissue cuttingdevice of claim 1 wherein the blade is connected directly to the bladeelevator balloon.
 10. The soft tissue cutting device of claim 1 whereinan amount of inflation of the blade elevator balloon is variable. 11.The soft tissue cutting device of claim 1 wherein the shaft includes aconduit configured to deliver the gas or fluid to the blade elevatorballoon and remove the gas or fluid from the blade elevator balloon. 12.The soft tissue cutting device of claim 11 further comprising a conduitconfigured to deliver and remove gas or fluid from the one or moreballoons.
 13. The soft tissue cutting device of claim 1 wherein theshaft further includes a blade base plate that attaches to the blade andis configured to support the blade, wherein the blade elevator balloonis positioned beneath the blade base plate.
 14. A transverse carpalligament cutting device, comprising: (a) a shaft having a top surface,two side surfaces and a bottom surface; (b) a shaft opening that extendsfor a distance along the top surface of the shaft; (c) a blade having atop cutting edge; and (d) one or more balloons coupled to the shaft thatexpand radially outwardly from the shaft; wherein the top cutting edgeis housed within the shaft and the one or more balloons are deflatedwhen the transverse carpal ligament cutting device is in an inactiveposition and wherein the top cutting edge extends upwardly through theshaft opening and the one or more balloons are inflated when thetransverse carpal ligament cutting device is in an active position,wherein the blade is coupled to a blade elevator balloon, wherein theblade elevator balloon inflates to extend the top cutting edge upwardthrough the shaft opening and deflates to retract the top cutting edgedownward through the shaft opening, and wherein the blade elevatorballoon is configured to receive gas or fluid for inflating the bladeelevator balloon so as to extend the top cutting edge upward through theshaft opening.
 15. The transverse carpal ligament cutting device ofclaim 14 further comprising a plurality of suction openings along thetop surface.
 16. The transverse carpal ligament cutting device of claim14 wherein the one or more balloons includes a lateral balloon thatexpands radially outwardly from one of the two side surfaces.
 17. Thetransverse carpal ligament cutting device of claim 14 wherein the one ormore balloons includes a dorsal balloon that expands radially outwardlyfrom the bottom surface.
 18. The transverse carpal ligament cuttingdevice of claim 14 wherein the one or more balloons includes a firstlateral balloon that expands radially outwardly from one of the two sidesurfaces, a second lateral balloon that expands radially outwardly fromanother of the two side surfaces, and a dorsal balloon that expandsradially outwardly from the bottom surface.
 19. The transverse carpalligament cutting device of claim 14 wherein the transverse carpalligament cutting device includes a proximal end configured as asingle-hand handpiece including one or more controls for activatingmovement of the blade and inflation and deflation of the one or moreballoons, wherein the one or more controls are configured to beactivated using a single hand.
 20. The transverse carpal ligamentcutting device of claim 14 wherein the blade elevator balloon isconfigured to provide uniform elevation of the blade along alongitudinal extent of the blade.
 21. The transverse carpal ligamentcutting device of claim 14 wherein the blade is connected directly tothe blade elevator balloon.
 22. The transverse carpal ligament cuttingdevice of claim 14 wherein an amount of inflation of the blade elevatorballoon is variable.
 23. The transverse carpal ligament cutting deviceof claim 14 wherein the shaft includes a conduit configured to deliverthe gas or fluid to the blade elevator balloon and remove the gas orfluid from the blade elevator balloon.
 24. The transverse carpalligament cutting device of claim 23 further comprising a conduitconfigured to deliver and remove gas or fluid from the one or moreballoons.
 25. The transverse carpal ligament cutting device of claim 14wherein the shaft further includes a blade base plate that attaches tothe blade and is configured to support the blade, wherein the bladeelevator balloon is positioned beneath the blade base plate.
 26. Atransverse carpal ligament cutting device, comprising: (a) a shafthaving a top surface, two side surfaces and a bottom surface; (b) ashaft opening that extends for a distance along the top surface and thetwo side surfaces of the shaft; (c) a blade having a cutting edge; and(d) one or more balloons coupled to the shaft that expand radiallyoutwardly from the shaft; wherein the cutting edge is housed within theshaft and the one or more balloons are deflated when the transversecarpal ligament cutting device is in an inactive position, and whereinthe cutting edge extends through the shaft opening and the one or moreballoons are inflated when the transverse carpal ligament cutting deviceis in an active position; wherein the blade is coupled to a bladeelevator balloon, wherein the blade elevator balloon inflates to extendthe cutting edge upward through the shaft opening and deflates toretract the cutting edge downward through the shaft opening, and whereinthe blade elevator balloon is configured to receive gas or fluid forinflating the blade elevator balloon so as to extend the cutting edgeupward through the shaft opening.
 27. The transverse carpal ligamentcutting device of claim 26 wherein the one or more balloons includes alateral balloon that expands radially outwardly from one of the two sidesurfaces.
 28. The transverse carpal ligament cutting device of claim 26wherein the one or more balloons includes a dorsal balloon that expandsradially outwardly from the bottom surface.
 29. The transverse carpalligament cutting device of claim 26 wherein the one or more balloonsincludes a first lateral balloon that expands radially outwardly fromone of the two side surfaces, a second lateral balloon that expandsradially outwardly from another of the two side surfaces, and a dorsalballoon that expands radially outwardly from the bottom surface.
 30. Thetransverse carpal ligament cutting device of claim 26 wherein thetransverse carpal ligament cutting device includes a proximal endconfigured as a single-hand handpiece including one or more controls foractivating movement of the blade and inflation and deflation of the oneor more balloons, wherein the one or more controls are configured to beactivated using a single hand.
 31. The transverse carpal ligamentcutting device of claim 26 wherein the blade elevator balloon isconfigured to provide uniform elevation of the blade along alongitudinal extent of the blade.
 32. The transverse carpal ligamentcutting device of claim 26 wherein the blade is connected directly tothe blade elevator balloon.
 33. The transverse carpal ligament cuttingdevice of claim 26 wherein an amount of inflation of the blade elevatorballoon is variable.
 34. The transverse carpal ligament cutting deviceof claim 26 wherein the shaft includes a conduit configured to deliverthe gas or fluid to the blade elevator balloon and remove the gas orfluid from the blade elevator balloon.
 35. The transverse carpalligament cutting device of claim 34 further comprising a conduitconfigured to deliver and remove gas or fluid from the one or moreballoons.
 36. The transverse carpal ligament cutting device of claim 26wherein the shaft further includes a blade base plate that attaches tothe blade and is configured to support the blade, wherein the bladeelevator balloon is positioned beneath the blade base plate.
 37. Thetransverse carpal ligament cutting device of claim 26 further comprisinga plurality of suction openings along the top surface of the shaft. 38.A soft tissue cutting method, comprising steps of: providing a softtissue cutting device comprising: (a) a shaft having a top surface, twoside surfaces and a bottom surface, wherein the shaft extends along alongitudinal axis; (b) a shaft opening that extends for a distance alongthe longitudinal axis and extends longitudinally along the top surfaceof the shaft; (c) a blade that extends through and withdraws from theshaft opening, the blade having a top cutting edge that extends in adirection parallel to the longitudinal axis, wherein the top cuttingedge is housed within the shaft when the soft tissue cutting device isin an inactive position, and the top cutting edge extends upwardlythrough the shaft opening when the soft tissue cutting device is in anactive position; (d) one or more balloons coupled to the shaft thatexpand radially outward from the shaft; and (e) a blade elevatorballoon, the blade being coupled to the blade elevator balloon, whereinthe blade elevator balloon inflates to extend the top cutting edgeupward through the shaft opening and deflates to retract the top cuttingedge downward through the shaft opening; advancing the soft tissuecutting device to a body region; expanding the one or more balloonsradially outwardly; and providing gas or fluid to the blade elevatorballoon to inflate the blade elevator balloon and extend the top cuttingedge upward through the shaft opening to cut soft tissue in the bodyregion.
 39. The method of claim 38 wherein the soft tissue cuttingdevice further comprises a plurality of suction openings along the topsurface of the shaft, wherein the method further comprises applyingsuction to the suction openings to suck air through the suction openingsso as to cause the soft tissue to move closer to the shaft.
 40. Themethod of claim 38 wherein the soft tissue cutting device furthercomprises one or more controls, the method further comprising:activating one of the one or more controls to cause the one or moreballoons to inflate; and subsequently activating one of the one or morecontrols to cause the blade elevator balloon to expand.
 41. A method ofcutting a transverse carpal ligament, comprising steps of: providing atransverse carpal ligament cutting device having an inactive positionand an active position, the transverse carpal ligament cutting devicecomprising: (a) a shaft having a top surface, two side surfaces, and abottom surface; (b) a shaft opening that extends for a distance alongthe top surface of the shaft; (c) a blade having a top cutting edge; (d)one or more balloons coupled to the shaft that expand radially outwardlyfrom the shaft, wherein the top cutting edge is housed within the shaftand the one or more balloons are deflated when the transverse carpalligament cutting device is in the inactive position, and wherein the topcutting edge extends upwardly through the shaft opening and the one ormore balloons are inflated when the transverse carpal ligament cuttingdevice is in the active position, wherein when the transverse carpalligament cutting device is in the inactive position the blade isunexposed and the one or more balloons are deflated, and wherein whenthe transverse carpal ligament cutting device is in the active positionthe blade is exposed and the one or more balloons are inflated; and (e)a blade elevator balloon, the blade being coupled to the blade elevatorballoon, wherein the blade elevator balloon inflates to extend the topcutting edge upward through the shaft opening and deflates to retractthe top cutting edge downward through the shaft opening; advancing thetransverse carpal ligament cutting device to a carpal tunnel regionwhile the transverse carpal ligament cutting device is in the inactiveposition; and providing gas or fluid to the blade elevator balloon toinflate the blade elevator balloon and extend the top cutting edgeupward through the shaft opening; and cutting the transverse carpalligament while the transverse carpal ligament cutting device is in theactive position.
 42. The method of claim 41 wherein the transversecarpal ligament cutting device further comprises a plurality of suctionopenings along the top surface of the shaft, wherein the method furthercomprises applying suction to the suction openings to suck air throughthe suction openings so as to cause the transverse carpal ligament tomove closer to the shaft.
 43. A method of cutting a transverse carpalligament, comprising steps of: providing a transverse carpal ligamentcutting device having an inactive position and an active position, thetransverse carpal ligament cutting device comprising: (a) a shaft havinga top surface, two side surfaces and a bottom surface; (b) a shaftopening that extends for a distance along the top surface and the twoside surfaces of the shaft; (c) a blade having a cutting edge; (d) oneor more balloons coupled to the shaft that expand radially outwardlyfrom the shaft, wherein the cutting edge is housed within the shaft andthe one or more balloons are deflated when the transverse carpalligament cutting device is in the inactive position, and wherein thecutting edge extends through the shaft opening and the one or moreballoons are inflated when the transverse carpal ligament cutting deviceis in the active position; and (e) a blade elevator balloon, the bladebeing coupled to the blade elevator balloon, wherein the blade elevatorballoon inflates to extend the cutting edge upward through the shaftopening and deflates to retract the cutting edge downward through theshaft opening; advancing the transverse carpal ligament cutting deviceto a carpal tunnel region while the transverse carpal ligament cuttingdevice is in the inactive position; providing gas or fluid to the bladeelevator balloon to inflate the blade elevator balloon and extend thetop cutting edge upward through the shaft opening; and cutting thetransverse carpal ligament while the transverse carpal ligament cuttingdevice is in the active position.
 44. The method of claim 43 wherein thetransverse carpal ligament cutting device further comprises a pluralityof suction openings along the top surface of the shaft, wherein themethod further comprises applying suction to the suction openings tosuck air through the suction openings so as to cause the transversecarpal ligament to move closer to the shaft.